Harmonizing Processes: The Respiratory Protective Devices Story
RPDs were an area of long-standing difficulty within the emergency preparedness field. Stockpiled by the federal government, by some states, and by the Centers for Disease Control and Prevention, a reliable supply of RPDs was important for protecting the public at large in the event of major public health crisis. The swine flu pandemic of 2009 had demonstrated confusion in the field related to RPDs and had left regulators keenly aware of deficiencies in the current system. Though the issues were very different from those faced by the battery group, the core challenge of working across diverse constituencies (in this case, agencies, manufacturers, and users) was similar.
RPDs fell under multiple regulatory authorities, depending on their use: under the FDA as medical devices; under the Occupational Safety and Health Administration as personal protective equipment; and under the National Institute for Occupational Safety and Health (NIOSH), an arm of the CDC, as disease prevention equipment. Unlike with batteries, the FDA had extensive expertise related to RPDs. Even within the FDA itself, multiple groups were involved—the premarket device review branch as well as the Office of Counterterrorism and Emerging Threats, the parent organization of EMCM. All of this complicated the process for manufacturers, who had to deal with multiple federal agencies with different approval requirements.
Suzanne Schwartz, the director of EMCM, had a mandate to harmonize processes both within and across federal agencies, to provide a more reliable stock of RPDs for use in the event of a pandemic by removing some of the burdens on the manufacturers. EMCM also hoped to reduce confusion among other stakeholder groups in the large RPD ecosystem, such as among health care delivery organizations, which were unsure about products to purchase and stock in hospitals. Much of the confusion had to do with which type of approvals the products required: Did they need both NIOSH and FDA clearance, or was NIOSH certification sufficient?
Aftin Ross, an EMCM fellow, was assigned to lead the planning and facilitation of the human-centered design portion of the workshop. As with the battery meeting, the RPD planning group selected the attendees with care, creating a stakeholder map at the outset to ensure that all relevant stakeholders—manufacturers such as 3M and Honeywell, regulators, academic researchers, health care managers and clinicians, and trade organizations—were invited to take part in the conversation.
THE STAKEHOLDER MAPPING TOOL
For the kinds of complex, multistakeholder problems often found in the social sector, stakeholder mapping can be a critical tool. It is easy to get caught in designing for end users while postponing consideration of the perspectives of other key stakeholders who will be crucial to the implementation of any new idea. Laying out the web of organizations involved in advance helps to ensure that the whole system is in the room when the conversation starts, and that teams are composed to maximize diversity.
Stakeholder map for respiratory protective devices.
The planning team did extensive work beforehand, meeting privately with the other federal agencies involved, to get them to the table. Even getting their internal partners at the FDA into the room required significant work on the team’s part, as Suzanne explained:
It’s worth pointing out how much it took to even get other groups within the FDA to actually come into the same room for these meetings. They often participated via teleconference even though we’re all in the same building! So we decided not to offer a telecom line. Everybody comes into the room together.
Meeting face-to-face, Suzanne felt, shifted the discussion in positive ways.
On May 21 and 22, 2014, the stakeholders convened to talk about challenges in the RPD space. In a series of breakout activities, they used design tools similar to those used in the battery workshop to identify challenge areas, and then they selected several to drill down into and proposed solutions to address them. Groups then presented their challenges and proposed solutions to the larger group. Once again, they used human-centered design techniques to give feedback on and refine the solutions proposed.
As the conversation proceeded, the team at EMCM discovered new insights that caused them to reframe their own definition of the problem. Aftin explained:
We found that some of the challenges we were focused on, from the agency perspective, were not the major issues for our stakeholders. This was very good for us to understand as we started to develop potential policy solutions. We also saw that, even though some of these problems were not necessarily within the FDA’s purview, they belonged to other stakeholders who were present, and they wanted FDA involvement in what came out of the human-centered design work. And they wanted copies of the products that groups presented during the summit meetings.
Ken, too, talked about what the FDA people learned:
It is easy at the FDA to see standards as being what matters, but in the meetings it became clear that the standards didn’t incorporate real-life experiences. We began to see a new reality: this particular standard is useful, but it’s not comprehensive enough to really guide us, or it doesn’t provide the solution that we need to overcome this challenge.
Aftin agreed:
When we came in, we thought that the standard, the testing, was really the main issue. What we learned from the summit was that, for our end users, it was really about the practice, the training, the education, knowing which device to use when, and making sure people had the appropriate fit for the device—all these training-related characteristics that were beyond the science question that we were concerned with. They were really about how do we best implement this in practice.
Aside from the concrete outputs of the meetings, this broadening and reframing of the agency’s own view was a key, albeit intangible, benefit of the conversation. As we saw already at Monash Medical Centre, solving a problem defined only from the supplier’s perspective risks wasted resources, as solutions may do little to create better value for the users or achieve the outcomes desired.
As with the dialogue on batteries, diverse ideas emerged during the RPD discussion, ranging from streamlining regulatory process, to training, to tracking devices within the hospital. Early on, the planning team had debated whether to constrain the conversation to specific topics. In deciding, instead, to allow the session’s participants to set their own boundaries in problem definition, the FDA team allowed for maximum learning. As Aftin noted:
We had gone back and forth in advance as to whether attendees would address the questions that we wanted them to address if we didn’t insist on it. Well, to a large part, they didn’t. But that turned out to be OK. What that told us was that what we maybe thought was an issue or problem was only an issue or problem for us.
Again, the assembled stakeholders were very positive about the experience; they liked the opportunity to take part in a working session instead of listening to presentations. The summit gave the stakeholders, including EMCM’s internal working team, new information to consider while working to harmonize processes. Aftin commented:
I think that the human-centered design activities really allowed us to put lots of things on the table—and even if people didn’t necessarily favor those ideas, they at least actually were put on the table. This was very important because the outcome that ends up resulting may not be what people expect when we start. If we hadn’t used some of those human-centered design activities, these would have been a tougher pill to swallow.
As they moved into policy development, the feedback and refinement resulting from the conversation paid off. The conversation allowed EMCM to produce better policies—ones that other stakeholders, having been part of the conversation, were now poised to better understand.
Reflections on the Process
The two FDA stories illustrate the potential of gathering together a set of diverse players from across the ecosystem and guiding them carefully through a new kind of conversation that avoids early negotiation and compromise and that aims for the creation of a productive dialogue rather th
an an adversarial debate. Such a structured process encourages the kind of creative collaboration that produces higher-order solutions to real-world challenges. Without this, people with expertise in different silos can easily talk past each other.
Though these conversations on batteries and RPDs, as well as the FDA’s role in each, were significantly different, design-led conversations and tools proved equally valuable in optimizing everyone’s problem-solving potential. Suzanne reflected:
Design thinking has been such an extraordinary tool for us internally because this is an area that is heavily emotionally charged for the groups that are involved, many of whom are very wedded to certain ways of doing things. Without the tools, these would be much more difficult conversations to have. The tools made it more about the problem as opposed to making it about the people involved. Just having the markers and the Postits on the table and putting people to work removed that emotional charge that I think would otherwise have existed.
For Ken, design thinking allowed the FDA to reach higher levels of engagement, which led, in turn, to greater openness to new possibilities:
It’s an amazing way to have people feel empowered and engaged. If you have a meeting of even ten or twelve people, what happens is a few people end up dominating the conversation and everyone else is just nodding or thinking, “I could speak up if that other person would shut up for two seconds.”
Besides promoting design thinking’s “totally different way of getting people to be open to different perspectives,” Ken argued that the creative collaboration represented by the battery and RPD conversations is becoming more and more critical for addressing complexity, especially as change in the medical regulatory device ecosystem accelerates:
When the FDA controls all aspects of the process, then maybe you don’t have to bring in the other stakeholders. But, in many cases, a government agency is at the crossroads of an issue—we don’t have complete control over it. And that’s when bringing people together and having a dialogue is really critical to making progress and addressing all of the important issues.
Suzanne agreed, noting that bureaucracies face inertia that is hard to surmount without collaborative thinking and action that broadens participants’ perspectives on critical issues:
The real challenge that we face in government is that we are a huge bureaucracy. It takes a lot to move things. We have found design thinking to be an excellent tool to help us move incrementally as well as stepwise. Making it about the methodology makes it about focusing on the problem rather than the person or the culture or the entrenched beliefs. It allows us to neutralize these charged discussions. By getting people comfortable with these exercises, folks are finally able to move away from attachments at the cultural and personal belief level and look at the problem in a more neutral kind of a manner.
CHAPTER SEVEN
Fostering Community Conversations in Iveragh, Ireland
THE CHALLENGE TO THE GREATER GOOD
We have looked at challenges that cross the boundaries of individual organizations. But what if the challenges lay within a community? Without the structure of specific roles and responsibilities, how can the conversation be orchestrated? The construction of community conversations has a long history of experimentation with different approaches. Despite significant effort, results have been mixed for some of the reasons we have already discussed—entrenched interests, conversations that go nowhere, and lack of local ownership of solutions—with the result that outcomes fail to materialize as momentum is lost.
DESIGN THINKING’S CONTRIBUTION
Design thinking can offer more than just a structured process for facilitating better team and organizational conversations; it can be scaled to foster and sustain a community-wide conversation that challenges participants to move beyond analyzing problems to generating solutions that can be shared and tested. Coupling design thinking with a process called a charrette, the Institute without Boundaries (IwB) in Toronto, Canada, teamed with the citizens of Iveragh—a beautiful Irish region on the Ring of Kerry that is beset with problems of unemployment and depopulation—to create a community-wide conversation that helped to imagine new possibilities in ways that pushed beyond good intentions to make them tangible and testable.
The Ring of Kerry on the Iveragh Peninsula is one of Ireland’s most visited tourist destinations, and for good reason: dramatic ocean scenery, ancient Celtic ruins, and the beauty of the Skellig Islands and the MacGillycuddy’s Reeks mountains. Yet this beautiful spot wrestles with the irony that few tourism dollars trickle down to the rural population. Tourists fly into and out of the airport near Killarney, spending almost all their money in that city’s restaurants, pubs, and hotels. From Killarney, they tour the Ring of Kerry in a single day, driving the coastline road around the Iveragh Peninsula in buses too large to access the small parking lots and the roads leading to most of the region’s archeological sites, family farms, and adventure opportunities.
But the region’s challenges go beyond capturing tourist dollars. Farming, a key source of income in the area, has suffered, as the unintended consequences of national and international political decisions, plus a dearth of market-bound transportation options, have gradually nudged the younger generation off the farm. Today, the average age of a south Kerry farmer is sixty-seven, and those remaining compete with cash-rich factory farmers and ranchers around the world. In general, unemployment on the peninsula is high, and well-paying private jobs are few. Throughout the area are neighborhoods of empty new houses, called “ghost estates,” built to be second homes for weekend vacationers from Dublin, Cork, and Limerick, who never came. Factories have closed, having succumbed to ever-greater international “subsidy shopping,” and Iveragh’s citizens have learned through the painful collapse of the so-called Celtic Tiger that if it sounds too good to be true, it probably is.
But behind the distanced economic language of unemployment, loss of tourist dollars, manufacturing flight, and unsold houses is a much more human—and painful—problem: Iveragh has lost its children.
“We have lost a generation,” Noreen O’Sullivan, the Cahersiveen community librarian lamented to us, “and we feel great sadness at having lost our young people.” Noreen grew up in the area but left to begin her education and then her career as a librarian. She was one of the fortunate ones, able to come home when the local library had an opening, but her three children have left, first to get an education and then to find jobs.
A local gardener, John Joe O’Sullivan, also described the loss in personal terms:
I live on a road which back in ’69 had twenty-nine children. Now, no school bus comes because there are no children left on that road. There are no pregnant women. In the past, I’d have to step off the footpath because of the pregnant women and their prams. Now, there are none.
With several closed elementary schools, south Kerry’s high school educates only two-thirds of the students it held a decade ago. Retired high school principal Michael Donnelly explained:
The area needs to do something. When I was principal in 1999, there were 780 students. Today, there’s a huge decline. In any community meeting today, there is a dearth of people in their twenties and thirties. And the young, vibrant, enthusiastic are vital to any community.
The desire to bring their children back led the Kerry County Council to an unlikely partnership with a Canadian design school—the Institute without Boundaries at Toronto’s George Brown College—and introduced them to the power of combining design thinking with a decades-old process from the architecture and urban planning world: the charrette.
Seeking to achieve social, ecological, and economic innovation, the IwB is an educational program focused on collaborative design. The IwB merges students from diverse academic and professional backgrounds with partner organizations around the globe to understand and tackle real-world challenges, with the aim of expanding decision-making creativity and cultivating the resources to support any innovative ideas developed.
> Jean Byrne, a Dublin transplant to Iveragh, was a catalyst in bringing the IwB across the Atlantic. With deep family roots in Kerry, Jean and her husband had vacationed on the Iveragh Peninsula for decades, building a second home they called Anam Cara (“soul friend” in Irish), with sweeping views over the rugged Atlantic. A neighbor, local farmer Michael O’Connor, invited Jean to attend a community meeting in Caherdaniel, a small village on the peninsula, to share with them her work using design thinking as a tool for civic engagement in Dublin. As a result, she was invited to join the local community group. The village was in the process of finalizing a five-year development plan. From Jean’s perspective, they were missing a more significant opportunity: leveraging the area’s natural beauty as a focus for developing economic activity and a sustainable community. Another problem she observed was that the small communities along the peninsula were all struggling with the same issues, but, as she described it, “They saw their problems in isolation rather than seeing the bigger picture that solutions might lay in connectivity and cooperation rather than competition.”
Design Thinking for the Greater Good Page 14
